Aerosol medication delivery apparatus with narrow orifice

ABSTRACT

An aerosol medication delivery apparatus includes a holding chamber having an input end and an output end and defining an interior space. The output end comprises an orifice having a cross-sectional area of less than about 60 mm 2 . In one preferred embodiment, the orifice has a circular cross-section. Preferably, the orifice has a diameter of between about 2.0 mm and about 7.50 mm. In one preferred embodiment, an inhalation and exhalation valve is located at the output end. A method of using the holding chamber is also provided.

This application is a continuation of U.S. application Ser. No.10/979,743, filed Nov. 2, 2004, which is a continuation of InternationalApplication PCT/US03/12121, with an international filing date of May 2,2003, which claims the benefit of U.S. Provisional Application No.60/377,528, filed May 3, 2002, the entire disclosures of which arehereby incorporated herein by reference.

BACKGROUND

The present invention relates to an aerosol delivery apparatus, and inparticular, to an aerosol medication delivery apparatus having a narroworifice.

Aerosol medication delivery systems are used, in general, to administermedication in aerosol form to the lungs of a user. For example, somesystems use a pressurized metered-dose inhaler (pMDI), which typicallyincludes a container in which the medication particles are stored underpressure, and an actuator used to dispense the medication from thecontainer. In other systems, a holding chamber is connected to one ofthe container or actuator, as shown for example in U.S. Pat. No.6,293,279, assigned to Trudell Medical International, and which ishereby incorporated herein by reference. The holding chamber reduces theneed for the user to coordinate activation of the pMDI canister withinhalation, helps reduce the delivery of nonrespirable medicationparticles from the canister, and helps reduce the impaction ofmedication particles in the user's oropharnyx and upper airway. In someconfigurations, shown for example in the U.S. Pat. No. 6,293,279 andU.S. Pat. No. 5,881,718, the apparatus can be provided with one or bothof an inhalation and exhalation valve(s) at an output end of thechamber. The output end is typically configured with a mouthpiece, whichis received in the mouth of the user, or with a mask, which is placedover the mouth and nose of the user.

Users of the aforementioned devices often suffer from various bronchialailments that can reduce lung capacity and output, which problems can beexacerbated with young children and domestic cats and dogs. Many ofthese devices, however, are not especially suited for users with lowtidal volumes, such as neonatals. In particular, such devices typicallyhave an orifice at the output end of the holding chamber that is greaterthan 78 mm². Such relatively large openings may not produce the sweepingforce necessary to draw aerosol out of a chamber with low tidal volumes,especially when the device is configured with inhalation/exhalationvalves. As used herein, the word “user” includes humans and animals,including domestic cats and dogs.

SUMMARY

By way of introduction, various preferred embodiments of an aerosolmedication delivery apparatus include a holding chamber having an inputend and an output end and defining a chamber housing having an interiorspace. The length of the chamber housing as measured from the input endto the output end is at least 70 mm and the diameter of the holdingchamber is at least 20 mm. In one preferred embodiment, the chamberhousing has a length of 120 mm and the diameter of the holding chamberis 40 mm. The output end comprises an orifice having a cross-sectionalarea of less than about 60 mm². In one preferred embodiment, the orificehas a circular cross-section. Preferably, the orifice has a diameter ofbetween about 2.0 mm and about 7.5 mm.

In one aspect, one preferred embodiment of the apparatus includes aninhalation and exhalation valve at the output end. In other aspects,methods of using the holding chamber are provided.

The foregoing paragraphs have been provided by way of generalintroduction, and are not intended to limit the scope of the followingclaims. The presently preferred embodiments, together with furtheradvantages, will be best understood by reference to the followingdetailed description taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an aerosol medication delivery system.

FIG. 2 is an exploded perspective view of the aerosol medicationdelivery system shown in FIG. 1.

FIG. 3 is an exploded perspective view of an alternative embodiment of aholding chamber.

FIG. 4 is a perspective view of one preferred embodiment of an adapter.

FIG. 5 is a side view of the adapter shown in FIG. 4.

FIG. 6 is a cross-sectional view of the adapter taken along line 6-6 ofFIG. 5.

FIG. 7 is an end view of the adapter shown in FIG. 4.

FIG. 8 is a side view of an alternative embodiment of an adapter.

FIG. 9 is a cross-sectional view of the adapter shown in FIG. 8 duringinhalation.

FIG. 10 is a cross-sectional view of the adapter shown in FIG. 8 duringexhalation.

FIG. 11 is an enlarged, partial cross-sectional view taken along line 11in FIG. 10.

FIG. 12 is a partial side view of an alternative embodiment of anaerosol medication delivery system.

FIG. 13 is a partial cross-sectional view of the aerosol medicationdelivery system shown in FIG. 12 taken along line 13-13 of FIG. 12.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

Referring to FIGS. 1 and 2, one preferred embodiment of an aerosolmedication delivery system includes a pMDI canister holding portion 2,or dispenser, coupled to a chamber housing 4, otherwise referred to as aholding chamber, at an input end 6 thereof. A medication container 8,for example a pMDI canister is disposed in a cavity 12 formed in thedispenser, with a stem of the canister being inserted into a well 10formed in the bottom of the dispenser. Preferably, the dispenser 2 ispivotally connected to the chamber housing 4 so that the dispenser 2 canbe pivoted and translated for storage inside the chamber housing whenthe device is not in use. The term “medication” or “medicament” andvariations thereof as used herein means any substance used in therapy.

In an alternative embodiment shown in FIG. 3, the apparatus does notinclude an integrated dispenser secured to the holding portion 20, butrather includes a backpiece 22 at the input end thereof. The backpiece22 is preferably made of an elastomeric material and includes an opening24 shaped to receive a mouthpiece portion of a separate pMDI dispenser.Various configurations of chamber housings and dispensers are shown inU.S. Pat. Nos. 6,293,279, 5,012,803, and 5,012,804, the entiredisclosures of which are hereby incorporated herein by reference. Itshould be understood that a holding chamber can also be used inconjunction with medication delivery containers other than a pMDIcontainer, including for example and without limitation nasal sprayersand powder inhalers.

As shown in FIGS. 1-3, the chamber housing 4, 20 defines an interiorspace 19 and further includes an output end 14, through which themedication is dispensed to the user. The length of the chamber housing4, 20 as measured from point A to B as shown in FIGS. 1 and 3 ispreferably between 70 mm and 160 mm in length and most preferablybetween 80 mm and 120 mm in length. The cross sectional area of thechamber housing 4, 20 is preferably between 700 mm2 and 7500 mm2 andmost preferably between 700 mm2 and 2100 mm2. In a preferred embodiment,the chamber housing 4, 20 has a length of 120 mm and a cross sectionalarea of 19.6 cm2.

As shown in the embodiment of in FIGS. 1 and 2, the output end 14includes a downstream portion 23 that is releasably secured to a mainhousing 21 with one or more fastening elements 25, 27. For example, thefastening elements can be configured as tabs and recesses in onepreferred embodiment, which provides a snap-fit between the main housing21 and the downstream portion 23.

In one preferred embodiment, shown in FIGS. 4-7, an adapter 30 includesan input end 32 configured as an insert portion that is fitted in anopening 27 formed in the output end 14 of the chamber housing.Conversely, the input end 32 can be fitted over or around an end portionof the chamber housing. The adapter further includes an output end 34that, in one preferred embodiment, is shaped to be received in the mouthof the user. For example, the output end 34 can have an outer circularcross-section, or it can be elliptical, oval, obround or any othershaped suitable for insertion into the mouth of the user. Alternatively,an additional mouthpieces (not shown) can be fitted in or around theoutput end. In yet another alternative, a mask (not shown) can be fittedin or around the output end, wherein the mask is shaped to be disposedover the face, preferably including the mouth and nose, of the user. Inyet another alternative embodiment, a nasal applicator, provided forexample with prongs, can be fitted into or around the output end.

A middle portion 36 joins the input and output end. In one preferredembodiment, the middle portion 36 has an inner, central portion 40 thatis tapered and follows the contour of an interior channel formed in theadapter. The shape of the middle portion, and in particular the centralportion 40, provides indicia to the user about which end to secure tothe holding chamber by indicating the flow direction. Additionalindicia, besides the shape, such as arrows and words, can also beprovided. Preferably, the middle portion includes a plurality of ribs 38extending radially from the central portion 40 which join the input andoutput ends 32, 34.

Referring to FIGS. 6 and 7, the channel 42 has an upstream end 44 and adownstream end 46, which terminates in and defines an orifice 47. In onepreferred embodiment, the channel 42 has a length of between about 20 mmand about 50 mm, more preferably a length of between about 25 mm andabout 40 mm, and even more preferably a length of about 32 mm.

Preferably, the downstream end 46 has a cross-sectional area that isless than the cross-sectional area of the upstream end 44. Preferably,the channel 42 tapers between the upstream and downstream ends.Preferably the ratio of the cross-sectional area of the channel at theupstream end to the downstream end is between about 1.5:1 and about 6:1,and more preferably at a ratio of about 4:1.

For example, in one preferred embodiment, the upstream end 44 has across-sectional area of between about 200 mm² and about 350 mm², andmore preferably about 283 mm², although greater and lesser areas may besuitable. In one preferred embodiment, the opening at the upstream end44 is configured as a circular opening having a diameter between about18 mm and about 20 mm, and more preferably a diameter of about 19 mm. Ofcourse, other non-circular shapes and/or cross-sectional areas areacceptable.

Also in one exemplary preferred embodiment, the downstream end 46, andthe orifice 47 formed at the end thereof, has a cross-sectional area ofbetween about 3 mm² and about 201 mm², more preferably between about 7mm² and about 78.5 mm², more preferably less than about 60 mm², evenmore preferably less than about 25 mm², and in one embodiment,preferably about 19.6 mm². In one preferred embodiment, the opening 47at the downstream end 46 configured is a circular opening having adiameter between about 2 mm and about 16 mm, more preferably betweenabout 3 mm and about 10 mm, more preferably less than about 7 mm, andmore preferably about 5 mm. Of course, other non-circular shapes and/orcross-sectional areas are acceptable. Also, it should be understood thatthe channel may have a uniform cross-sectional area between the upstreamand downstream end, preferably in the dimensions and ranges describedabove with respect to the downstream end.

In one preferred embodiment, an initial length 48 of the channel at theupstream end, for example about 4 mm, has a uniform cross-sectionalarea.

Thereafter, the channel preferably tapers. For example, in one preferredembodiment, the channel includes a transitional region 50 having aconcave shape, for example with a radius of about 20 mm, afrusto-conical portion 52, and a lower transitional region 54 having aconvex shape, for example with a radius of about 20 mm. A final length56 of the channel at the downstream end, for example about 2.92 mm,preferably again is configured with a uniform cross-sectional area.Preferably, the angle of the sidewalls of the conical portion is about22° from the central axis 58, forming an angle A of about 44°. Ofcourse, it should be understood that the curved transitional regions canbe eliminated, or provided with different radii of curvature. Likewise,the lengths of the initial and final lengths of the channel can beomitted, and also the linear portion between the curved transitionareas, such the entire cross-sectional area is tapered or changes alongthe length of the channel. Alternatively, the channel may be steppeddown from a first cross-sectional area to a lesser secondcross-sectional area, without any taper.

Referring to FIG. 6, the downstream end 46 of the channel 42, with itsorifice 47, opens into an exhaust chamber 60 formed in the output end 34of the adapter. Preferably, the exhaust chamber 60 has a length of about16 mm, and a cross-sectional area of about 177 mm². In one preferredembodiment, the exhaust chamber 60 has a circular cross-section with aninner diameter of about 15 mm. In one preferred embodiment, anendotracheal (ET) tube having an outer diameter of about 15 mm isconfigured to fit therein.

Referring to another preferred embodiment of the adapter, shown in FIGS.12 and 13, the middle portion 90 is configured with a radially extendingannular rib 62 positioned between the output and input ends. The rib 62forms a shoulder 64 having a recess or annular channel 66 which receivesan end 69 of the housing and limits the distance the adapter is insertedinto the end of the chamber housing. A shoulder 68 also defines anoutwardly facing annular channel 70 or recess that may receive theflange of a mouthpiece or mask as it is inserted onto or around theoutput end of the adapter. Referring to FIG. 13, the exhaust chamber 60extends around the output end of the channel, to direct the aerosol intothe center of the ET tube adapter or center of the mask connector.

In yet another preferred embodiment of the adapter, shown in FIGS. 8-11,the output and input ends are made as separate pieces 100, 102 that aresecured one to the other in a snap-fit engagement, or by other devicessuch as a friction fit or locking device. In this embodiment, a valve110, which serves both as an inhalation and exhalation valve, has anouter peripheral edge 112 configured with an enlarged portion or beadthat is trapped and secured in a cavity 104 formed between the outputand input pieces. The valve 110 includes a flexible U-shaped hingeportion 114 extending between the edge and a base portion 116 of thevalve. The base portion has a first and second side 118, 120. The firstside 120, which is directed toward the output piece, defines a sealingsurface that mates with an annular rib portion 122 of the output piece.The rib portion 122 is spaced from an end surface 126 of the input pieceto form an exhaust channel 124 therebetween, with the base portion 116disposed therebetween in the exhaust channel 124. The valve 110 furtherincludes a duckbill portion, having a pair of flat, flexible side walls128, which extends upwardly from the periphery of a central openingformed in the base portion 116 and defines an apex 130. Preferably aslit is formed at the apex 130. The output piece 102 further includes aplurality of openings 132, or exhaust ports, that communicate with theexhaust chamber 60 of the adapter via the exhaust channel 124.Preferably, the valve 110 is circular, and includes an annular baseportion 116, hinge portion 114 and edge portion 112.

It should be understood that the adapter could be molded as a one-pieceunit with the valve being in-molded with the adapter, or inserted as aseparate component. In addition, it should be understood that the valvecan be configured in different shapes and can include a valve that has acentral opening with a peripheral portion of the valve being seated on avalve seat, for example a baffle member secured in or adjacent to thechannel. In such a configuration, the central portion moves away fromthe valve seat during inhalation, while an outer peripheral edge of thevalve moves away from a valve seat formed on the output piece duringexhalation. It should also be understood that the device can beconfigured with separate inhalation and exhalation valves.

It should be understood that the channel 42, with its downstream andupstream ends 46, 44 can be formed integrally in the output end of thechamber housing, for example by molding, without the need for anadapter. Likewise, the output end of the adapter, defining themouthpiece, can be formed integrally as part of the chamber housingdownstream of the channel. Alternatively, the output end of the adaptercan be formed as a separate piece that is mounted to the chamberhousing, having a channel, with a valve disposed therebetween asexplained above with respect to FIGS. 8-11. As such, it should beunderstood that the term “output end” of the holding chamber includesthe adapter when it is associated therewith. Likewise, it should beunderstood that the term “chamber housing” includes and incorporates theadapter when it is mounted thereto.

Preferably, the adapter 30 and the chamber housing 14 are made of a hardplastic, such as polypropylene. The valve member 110 is preferably madeof a flexible material, including for example and without limitation asilicone, a thermoplastic elastomer, rubber,Ethylene-Propylene-Diene-Monomer (EPDM) or Berfluodelaastomers (FFKN).

In operation, the user actuates the dispenser 2, or other device, so asto discharge a medication, preferably in aerosol form, through the inputend 6 into the interior space of the holding chamber 4, or chamberhousing. The user thereafter inhales through the output end of theadapter 34, 102 and holding chamber. As the user inhales, themedicament, which is preferably in aerosol form, is drawn through thechannel 42 from the upstream to the downstream ends 44, 46 thereof. Themedicament is then expelled into the exhaust chamber 60 and through theuser's mouth via an ET tube where it is deposited in their lungs.

In one preferred embodiment, which includes an inhalation and exhalationvalve 110, the edges of the flat sidewalls 128 of the duck bill moveaway from each other at the slit formed at the apex 130 upon inhalationdue to a pressure differential applied to the upstream side of theduckbill, so as to allow the medicament to move through the openingformed thereby. At the same time, the pressure is applied to theupstream side 118 of the base portion so as to seal the downstream side120 against the valve seat formed by the rib portion 122.

Upon exhalation, a pressure is exerted on the downstream side of thesidewalls 128 causing the duck bill to close. The exhalation pressure,however, is also exerted on the downstream side 120 of the base portion116, causing the base portion 116 to move away from the valve seat 122as the hinge flexes 114. As the base portion 116 is unseated, theexhaust air from the user escapes through the channel 124 and openings132 to the ambient environment. In this way, exhalation by the user doesnot force air, or any contaminants, back into the holding chamber 4.

The narrow orifice 47 formed in the output end 14, whether integrally orby way of an adapter, is ideally suited for administering medication tousers or patients with low tidal volumes in the range of between about 5ml to about 100 ml, and more preferably between about 5 ml and about 20ml. The term “tidal volume” as used herein means the average volumeinhaled and exhaled during periodic breathing, and generally needed tosatisfy metabolic requirements. In particular, the narrow orifice 47,alone and in conjunction with the tapered channel 42, maximizes theemitted dose and respirable fraction of the aerosol. In particular, thevelocity of the particles is increased and, is particularly concentratedalong the axis or centerline of the channel 42. The increased velocitymay increase the number of respirable particles from the population oflarger particles, as well as help carry the particles through thesystem.

The holding chamber with its narrow orifice, whether integrally moldedor formed in an adapter portion thereof, is suitable for bothspontaneously breathing patients as well as those requiring assistedventilation.

Although the present invention has been described with reference topreferred embodiments, those skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention. As such, it is intended that the foregoingdetailed description be regarded as illustrative rather than limitingand that it is the appended claims, including all equivalents thereof,which are intended to define the scope of the invention.

1-27. (canceled)
 28. An aerosol medication delivery apparatuscomprising: a holding chamber having an input end and an output end,said holding chamber defining an interior space between said input andoutput ends, wherein said output end comprises an orifice having across-sectional area of less than about 60 mm², an inhalation valvedisposed downstream of said orifice and an exhalation valve disposeddownstream of said orifice.
 29. The aerosol medication deliveryapparatus of claim 28 wherein said cross-sectional area of said orificeis a first cross-sectional area, wherein said holding chamber comprisesa chamber housing defining said interior space defined by a secondcross-sectional area greater than said first cross-sectional area, aninlet at said input end, and an outlet at said output end, said outletdefining a third cross-sectional area less than said secondcross-sectional area and greater than said first cross-sectional area,and an adapter releasably secured to said chamber housing at saidoutlet, wherein said adapter defines said orifice.
 30. The aerosolmedication delivery apparatus of claim 29 wherein said adapter comprisesa mouthpiece shaped to be inserted into the mouth of a user.
 31. Theaerosol medication delivery apparatus of claim 29 wherein said adapterincludes said inhalation and exhalation valves.
 32. The aerosolmedication delivery apparatus of claim 28 wherein said inhalation andexhalation valves are integrally formed.